Neoadjuvant Chemotherapy in Non Small Cell Lung Cancer (NSCLC) Stages IB, IIA, IIB, and IIIA/T3

Phase 3

Terminated

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT00273507
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

Randomised trial of chemotherapy or not before surgery in early resectable stages of NSCLC (IB, IIA, IIB, and IIIA/N2).

Detailed Description

Randomisation between 3 courses of neoadjuvant Carboplatin plus Paclitaxel or no chemotherapy before surgery.

Study Timeline

• Study Start: 1998-01
• Study Completion: 2006-01
• Study First Submitted: 2006-01-05
• Study First Submitted QC: 2006-01-05
• Study First Posted: 2006-01-09
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-17
• Last Update Posted: 2009-09-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• NSCLC
• Stages IB, IIA, IIB, IIIA/T3
• Lung function test allowing surgery
• Age 18-75 years

Exclusion Criteria

• Poor lung function
• Performance status 3-4
• Mediastinal lymph node involvement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Survival

Secondary Outcome Measures

Name	Time	Method
Time to progression
Complete resection rate

Trial Locations

Locations (1)

Dept. Oncology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark